Position paper for the interpretation of device related changes

It is Team-NB’s position that device component changes should be assessed in accordance with the principles applied to medical device substantial change assessments to confirm that the device component remains in compliance with Annex I of MDR 2017/745.

This position paper is intended as a guide for the determination of proposed substantial changes to the device component of a drug device combination product.

You will find the position paper of Team Notified Bodies here.